What are the responsibilities and job description for the Director, Clinical Data Management position at iO Associates - US?
Our Client, a leading oncology medicines company, is seeking an experienced and dynamic Director for Clinical Data Management to join their team. In this role, you will be responsible for overseeing all clinical data management activities for our client's cutting-edge clinical studies. This position offers an incredible opportunity to make a significant impact in the field of oncology and further the development of innovative cancer therapies.
Responsibilities to include:
- Build and lead a team of talented data management professionals, ensuring the quality and efficiency of data collection, cleaning, and integrity.
- Collaborate with vendors involved in clinical data management, such as electronic data capture (EDC), electronic patient reported outcomes (EPRO), interactive response technology (IRT), and data visualization, to ensure the timely delivery of high-quality data.
- Develop and review study plans and protocols to guarantee that data collection and case report form (CRF) design align with study objectives and regulatory requirements.
- Create and maintain data processes and standards, ensuring seamless integration and data quality from various data sources.
- Establish and implement best practices for data collection, edit specifications, data management plans, data systems validation, and other processes related to data management.
- Prepare for audits and regulatory inspections, ensuring the quality and integrity of clinical databases and adherence to CDISC standards and industry regulations.
- Generate meaningful metrics, reports, dashboards, and analytics to measure the performance of the Clinical Data Management team.
- Act as a subject matter expert and represent the Clinical Data Management team at department meetings and in vendor engagements, including providing expertise in outsourcing solutions and participating in the RFP process.
Experience required:
- A bachelor's or higher degree in science, biology, mathematics, or computer science. CCDM certification preferred.
- Experience with project management principles. PMP certification is a plus.
- Understanding of data manipulation using SAS, R, or Python/Pandas
- Familiarity with CDISC/SDTM standards is essential.
- Experience in managing Data Management CROs and reviewing clinical data.
- Strong expertise in data standardization and experience with EDC systems.
- Practical familiarity with building studies using CDISC/CDASH standards.
If you are a dedicated professional with a passion for groundbreaking research and making a difference in the lives of cancer patients, we invite you to apply. This position is based in Boston, MA, with periodic travel requirements.
